Table 2.
Late-phase clinical trials with blisibimod in SLE
| Clinical trial | Phase | Status | SLE population | Exclusion criteria | Primary outcome/results | Reference |
|---|---|---|---|---|---|---|
| CHABLIS-SC1 NCT01395745 |
III | Completed 9-2016 | Age ≥18 years SELENA-SLEDAI ≥10 On stable GC dose +ANA and/or +ds-DNA |
Active CNS Active LN Vasculitis Cytopenia |
Proportion of patients achieving SRI at 52 weeks | Scheinberg et al102 |
| CHABLIS-SC2 NCT02074020 |
III | Withdrawn prior to enrollment | Age ≥18 years SELENA-SLEDAI ≥10 ±Stable LN On stable GC dose +ANA and/or +ds-DNA |
Active CNS Vasculitis Cytopenia |
Proportion of patients achieving SRI-8 at 52 weeks | NA |
| CHABLIS 7.5 NCT02514967 |
III | Recruiting 6-2016 | Age ≥18 years SELENA-SLEDAI ≥10 ±Stable LN On stable GC dose +ds-DNA and low C3 or C4 |
Active CNS | Proportion of patients achieving SRI-6 at 52 weeks | NA |
Abbreviations: SLE, systemic lupus erythematosus; SELENA-SLEDAI, SLE disease activity index with SELENA modification; SRI, SLE responder index; GC, glucocorticoid; ANA, antinuclear antibody; ds-DNA, double stranded DNA; +, positive; CNS, central nervous system; LN, lupus nephritis; SRI, SLE responder index; NA, not available; C3, complement component 3; C4, complement component 4.